• 한국임상약학회지
• /
• 제21권1호
• /
• pp.22-29
• /
• 2011

Purpose: This study aims to investigate how gender-based differences are actually reflected on drug approval. Methods: Data on gender-based differences of drugs were analyzed by searching PDR (Physician's Desk Reference) with the keyword, "GENDER". Results: There were descriptions related to gender in product directions of 361 drugs in 2009 PDR, out of which 63 items actually showed gender-related differences. Drug categories showing comparatively high gender-based differences were nervous system, cardiovascular system, and alimentary tract and metabolism. Pharmacokinetic differences between genders were observed most frequently; compared to men, 32 drugs showed higher absorption while 18 drugs revealed lower clearance in women. There were 2 drugs which gender should be considered before prescribing, and 5 drugs which showed different severity of adverse effects according to gender. Conclusions: It is necessary to establish domestic policies for drug approval and use which reflects gender-based differences through sufficient researches.

• 한국산학기술학회논문지
• /
• 제19권8호
• /
• pp.360-369
• /
• 2018

국내 제약 산업에는 2012년부터 혁신형 제약기업 인증 지원 정책이 시행되고 있다. 이 연구는 이 정책의 형성과정 및 정책만족도에 대한 이해관계자와 관련 전문가의 인식을 파악하고, 정책만족도를 설명하는 요인을 파악하기 위해 수행하였다. 혁신형 제약기업을 포함하여 제약기업, 대학, 정부출연연구소 관계자를 대상으로 이메일, 팩스 등을 통해 설문조사하였으며, 유효 응답률은 38.4% (61/159) 였다. 연구결과 정책형성과정 중 정책필요성(정책문제설정 단계)에 대한 인식이 가장 긍정적이었으며, 다른 모든 단계와 정책만족도에 대한 인식은 보통 수준이었다. 응답자 개인 변인 및 정책형성과정에 대한 인식 변인 중 정책만족도와 관련이 있는 변인을 대상으로 다중회귀분석을 통해 영향 요인을 살펴본 결과, 정책결과 및 정책집행 단계의 일부 변인이 주요 요인으로 분석되었다. 구체적으로 정책만족도에 가장 큰 영향을 미치는 요인은 인증기업의 성과(정책결과 단계)에 대한 인식인 것을 확인하였다. 또한 적정성 및 사후관리 능력(정책집행 단계)에 대한 인식 역시 정책만족도에 미치는 영향력의 크기가 유사했다. 이는 수요자의 정책만족도에는 정책결과뿐만 아니라 정책집행과정에 대한 인식이 중요하다는 것을 시사한다. 다만 정책 시행 초기에 수행되는 등의 한계로 인해 향후 추가 연구를 통해 검증 및 보완이 필요하다.

• 보건행정학회지
• /
• 제21권3호
• /
• pp.425-456
• /
• 2011

Background: Organizations in the pharmaceutical industry are highly dependent on the institutional environment. The introduction of pharmacoeconomics to the decision-making on the price and reimbursement decisions became strong constraints to pharmaceutical companies in Korea. As little is known about the issue on organization-environment interaction in the healthcare field, this study aimed to figure out how pharmaceutical companies adapted to the environmental changes. Methods: A multicase study method was used, selecting eight cases among multi-national pharmaceutical companies in South Korea. In-depth interviews were conducted with the managers of these organizations, and secondary data were reviewed to complement the interviews. Results: Pharmaceutical companies viewed the new policies as a big threat and sought for actions against them. One of the most distinguishing organizational changes was to construct a Market Access department. Other strategies managing the environment such as co-optation, forecasting, and bargaining were also implemented. These changes were consistent with the predictions of Resource Dependency Theory and Institutional Theory. Conclusions: The interactions between pharmaceutical companies and institutional environments in healthcare were first explored. This study presents a new perspective on how organizations change and the motives for the changes. The findings of this case study will form the basis of further empirical studies.

• 대한한의학방제학회지
• /
• 제21권2호
• /
• pp.29-43
• /
• 2013

Objectives : The aim of this study is reviewing the past legal definition and regulations, to provide basis for the future desirable direction of Korean herbal pharmaceutical industry and national herbal drug policies. Methods : We reviewed how concept of herbal medicinal preparation has been utilized and changed along with various national laws and regulations. And this study also reviewed problems related herbal medicinal preparation policies. Results : Since 1990s, especially inauguration of Korea Food & Drug Administration (KFDA) at 1998, the concept of crude drug preparation has constantly expanded and distorted the scope of herbal medicinal preparations. This resulted in decline of herbal medicinal preparation industry. Conclusions : It means policies related herbal medicinal preparation which was driven steadily during this decade have lost their consistency. Also, it restricted the various medical options which can guarantee people's health rights.

• 보건행정학회지
• /
• 제22권4호
• /
• pp.561-578
• /
• 2012

This study was performed in order to compare a change in pharmaceutical expenditures per outpatient of clinic and to analyze factors relevant to a systems as part of evaluating policies for the incentive scheme to reduce total prescribed drug expenditure and for the drug utilization review system("DUR system" hereafter). For this, it had finally analytical subjects as 21,320 clinics nationwide without a change in location, clinics symbol and signed subject during both terms of the first half of 2010 and the first half of 2011. As a result, the odds ratio with reduction in pharmaceutical expenditures of clinic was statistically higher significantly in the shorter year number of opening clinic, in the larger number of doctors, when the classification of establishment is other, not individual, and when the signed subject is surgical division. Also, the odds ratio was significantly higher in the less patient number of clinic and in the lower ratio of patients aged over 65. Finally, the odds ratio was significantly high when a clinic had been located in DUR system demonstrative project area. Through this, a case of policy for improvement in doctor's autonomous prescription behavior like DUR system can be known to be effective for reduction in pharmaceutical expenditures. A future research on evaluation of policy for pharmaceutical expenditure management system will need to be performed in-depth analysis in consideration of diverse characteristics on the participatory entities.

• 한국임상약학회지
• /
• 제31권4호
• /
• pp.257-267
• /
• 2021

Background: The need for regulatory science development to evaluate advanced regulatory products is gradually increasing without hindering the technological development. Creating a research environment and fostering experts through the establishment of regulatory agency-led policies are essential for the development of regulatory science. Method: This is a comparative study of the United States, Japan, Singapore, and Korea. The literature and websites of each regulatory agency were reviewed, and the focus was on advantages and comparing advantages based on definition, development trends, and expert training projects. Results: The United States is striving to develop regulatory science in response to changes in the new pharmaceutical industry through the regulatory science report, and to foster expert both inside and outside the Food and Drug Administration (FDA). Japan is promoting regulatory science centered on regulatory science centers, and is focusing on researching work-related regulatory science within the Pharmaceuticals and Medical Devices Agency (PMDA) and improving employees' ability to make regulatory decisions. Singapore was aiming to improve Southeast Asia's regulatory capabilities under the leadership of Centre of Regulatory Excellence (CoRE) within Duke-NUS University. In 2021, Korea is in its early stages, starting to run a university's degree program related to regulatory science this year. Conclusion: Regulatory science should be developed with the aim of improving the regulatory ability of the Ministry of Food and Drug Safety with Korea's independent concept of regulatory science.

• 한국의사학회지
• /
• 제26권2호
• /
• pp.175-185
• /
• 2013

Purpose : The current Medical Law and the Pharmaceutical Affairs Act, which are incapable of utilizing the research results and the advanced academic, clinical, and pharmaceutical system of the present-day Korean (Oriental) medicine, have limitations and create a paradox by provoking social conflict among the professionals in the field. The aim of this study was to find out the legal and systematic problems that contributed to a complicated conflict amongst Korean (Oriental) medicine doctors, doctors, pharmacists, and Korean (Oriental) pharmacists regarding the classification of their functions. Methods : We reviewed the history and characteristics of the legislation regarding the duties of Korean (Oriental) medicine doctors and Korean (Oriental) pharmacists as well as the relevant and important public health policies since the enactment of the National Medical Services Law in 1951. We focused on the laws and regulations that are made in the process of the separating functions of physicians and pharmacists and the dispute between the Korean (Oriental) medicine doctors and the Korean (Oriental) pharmacists in the 1990s and 2000s. Results : The legislations and amendments of the medical and pharmaceutical laws and regulations that reflect the modern academic, clinical, and pharmaceutical system of the Korean (Oriental) medicine and the research results could be summarized as follows: 1) A partial amendment of the Medical Law in 1987, which added the provision of "Oriental health guidance" as one of the duties of Korean (Oriental) medicine doctors, assured a place for Korean (Oriental) medicine doctors in the field of public health. 2) A partial revision of Pharmaceutical Affairs Act in 1994 established a new system for Korean (Oriental) pharmacists, bringing about the creation of dualistic pharmaceutical system that complements the dualistic medical system. 3) The Promotion of the Research and Development of Wonder Drugs by Using Natural Substances Act was legislated in 2000 in order to stimulate research and development of Korean (Oriental) medicine and its industrialization. 4) Oriental Medicine Promotion Act in 2003 was enacted to lay foundation to specify and promote technology and industry that are related to Korean (Oriental) medicine. Discussions and conclusions : Although the dualistic medical and pharmaceutical system is set up by the Medical Law and Pharmaceutical Affairs Act, it is shown that the relevant regulations have been developed from a perspective of the western medicine.

• Journal of Preventive Medicine and Public Health
• /
• 제13권1호
• /
• pp.53-66
• /
• 1980

The editorials of the leading newspapers may reflect as well as help formulate the public opinions to a significant degree. Bearing this in mind, this study was carried out to provide information useful in formulating such public health policies that could practically meet the social interests and demands in health appearing in the editorials of the newspapers. This analysis covered the editorials of 5 leading newspapers such as Donga Ilbo, Chungang Ilbo, Hankook Ilto, Chosun Ilbo and Seoul Shinmoon for about 10 years from Jan. 1st, 1970 through Oct. 31th, 1979. The major findings are as follows: 1. The total number of health-concerned editorials in the five daily papers for the period was 1,768 or occupied 6.4% of the total editorials of the same sources. The increasing trend of frequnecy of the health-concerned editorials since 1976 indicates the increment of social interests and demands in health. Analysing the contents, environmental pollution received the greatest attention in those editorials, which was followed by medical affairs, environmental sanitation, and disease control in order in terms of frequency of appearance. However, there was a tendency that the interests in the environmental pollution, medical affairs and social welfare tended to increase year by year, whereas those in environmental hygiene and disease control comparatively decreased. 2. Motives of dealing with the health-concerned editorials were provided by announcement of the governmental policies and implementation for 25.6% and by out-breaks of the relevant events for 23.9%. This tendency coincides with the general characteristics of the editorials that reflect the timely issues. Closely analysing, however, the fact that the motives engendered by the out-breaks of the relevant events or by the season concerned comparatively tended to decrease as years pass by, indicates that the editorials tend more to seek the future-oriented demands in health rather than the current issue-oriented. 3. The editorials appeared to be more concerned with the governmental policies. 95.7% of all the editorials analysed were addressed to the government. This signifies the role of government in the field of public health and medical affairs. Their attitudes toward health-related policies of the government were much more negative than the other editorials that were addressed to the government in other fields. This suggests that the governmental interests in health were neither sufficient nor fair. 4. What the editorials most stressed were; (1) increment of governmental interests in health, (2) improvement of the governmental health administration, (3) enriching the basic statistics, and (4) development of various technologies pertinent to health affairs and disease control, and so forth. However, must of their suggestions were not concrete but rather abstract and conceptual. 5. The editorials also expressed strong interests in research area. The areas of the needed research most suggested by items are; (1) development of effective health care delivery system, (2) establishment of more practical system of calculating medical cost, (3) implementation of effective policies to control degenerative diseases, (4) division of medical care services and pharmaceutical services systems, (5) effective ways to prevent Co poisoning accidents, (6) changing status of environmental pollution and its effects upon health, and (7) status of occupational diseases, and so forth. 6. There were some editorials -not small in quantity -that have risk to mislead the public opinions as well as the health policies due to lack of professional knowledge of the writers. It is desirable to establish some kind of mechanism that screens the erroneous contents of the editorials to help prevent misleading opinions.

• 대한예방한의학회지
• /
• 제17권1호
• /
• pp.181-197
• /
• 2013

Objectives : This study aimed to assess the differences in treatment behavior by reviewing data of a medical institution that studies treatment behavior in URI and assessing the treatment efficacy in Korea. Methods : We analyzed the behavior of medical customers and providers of upper respiratory infection medications using the NPS published by the Health Insurance Review Assessment Service. We created an operational definition for complications, and confirmed the difference in complication distribution between medical specialties. We also performed a multivariate analysis using a mixed model to elucidate the factors influencing the occurrence of complications. Results : The outcomes of analyzing factors to influence the difference in practice patterns of the diagnosing URI between the physicians are as follows; (1) Analysis of antibiotics prescriptions rate showed significant difference from medical departments (pediatrics; 49.7%, internal medicine; 54.2%, otorhinolaryngology; 69.6%, family medicine; 61.6%, general surgery; 57.5%, p<0.001). Analysis of steroid prescriptions rate showed significant difference from medical departments (pediatrics; 3.8%, internal medicine; 4.5%, otorhinolaryngology; 5.4%, family medicine; 3.0%, general surgery; 11.2%, p<0.001). (2) In patients who visited medical institutes with the common cold, the complication distribution differed according to the medical specialty, which suggests that specific complications arise depending on the particular medical specialty (p<0.001). (3) Moreover, through multivariate analysis, we found that the complication rate is higher in clinics than in hospitals, depending on the institute's size. (p<0.001; odds ratio of 4.67 in clinics than in hospitals, 95% CI 2.66-8.21) Conclusions : We observe a deviation between the behavior of patients diagnosed with URI and medication providers. This may arise from the interaction between providers and consumers, wherein the complications are associated with the choice of outpatient department and the prevention of cutting incentives. These findings suggest that the health policies should be improved to prevent inappropriate medical practice in the treatment of pediatric URI.

• 대한한의학회지
• /
• 제28권1호통권69호
• /
• pp.42-50
• /
• 2007

Objectives . This study was to assess the Korean Traditional Medicine forecast subjects that had been expected to be accomplished by 2005. The result will help the Korean medical society plan far policies and studies on Korean Traditional Medicine. Methods : Assessed targets were 64 subjects (expected to be studied until 2005) of the total 93 subjects from the 'Mid- to Long-Term Forecast and Plan Study for Korean Traditional Medicine'. The subjects were classified into two types : political subjects and research and development (R&D) subjects. These were determined by the quantity and contents of related political reports, political research projects, thesis, patent, placing products on sale, etc. Results :1) 5 items of a total 12 political subjects were accomplished or partially accomplished (41.7%), and 9 items of a total 46 R&D subjects were accomplished or partially accomplished (9.5%). 2) While the accomplishment percentage (accomplished or partial accomplished) in literature arrangement and D/B construction field was 100%, it was under 10% in product or system development field. Thus, it seems that practical subjects were less accomplished than academic subjects. 3) On 8 subjects of 'Forecast Research on Future of Oriental Medicine' which had been performed in Japan, the Korean expected dates when the subjects would be realized were earlier than the Japanese ones, but no subjects were realized. Conclusion · Political and academic subjects weir accomplished more than R&D and practical subjects.